US FDA delays action on Auxilium's Peyronie's sBLA

USA-based Auxilium Pharmaceuticals (Nasdaq: AUXL) says that the US Food and Drug Administration has notified the company that it is extending the Prescription Drug User Fee Act (PDUFA) goal date for its supplemental Biologics License Application for Xiaflex (collagenase clostridium histolyticum) for the treatment of Peyronie's disease (PD) from September 6 to December 6, 2013.

Xiaflex has already been approved by the US FDA, Health Canada and the European Medicines Agency as a treatment for Dupuytren's contracture, and is also in development in Japan.

During the course of recent product label discussions, Auxilium submitted revisions regarding the company's proposed Risk Evaluation and Mitigation Strategy (REMS) program and other aspects related to the proposed label. The FDA determined that this submission qualified as a major amendment filed during the final three months of the review and extended the PDUFA goal date to December 6, 2013. The FDA has not requested that any additional clinical studies be performed prior to the revised PDUFA action date.